Signature Diagnostics to Present a novel Companion Diagnostic Product
Predicting
Response to Cetuximab in Colorectal Cancer at the 102nd AACR Meeting in
Orlando
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Potsdam, Germany, April 6, 2011 - Signature Diagnostics AG announced today
that
the company was selected to present its novel companion
diagnostics for
predicting response to Cetuximab in patients with colorectal cancer (CRC)
of all
stages at the 102nd Annual Meeting of the American Association for
Cancer
Research (AACR) in Orlando on April 2-6, 2011.

The paper, "BRAF and PIK3CA mutations in addition to KRAS improve
prediction of
resistance to Cetuximab in a large panel of colon carcinoma
xenografts" was
presented at the late breaking poster session on April 5, 8:00am-12:00am.

This innovative proprietary companion diagnostic (CDx-Cetuximab)
comprises the
detection of the mutation status of PIK3CA and BRAF in addition to KRAS
for the
accurate prediction of response to Cetuximab, an approved anti-EGFR
antibody, in
patients with CRC of all four stages, especially in UICC stage II and
III.
Wild-type PIK3CA, BRAF and KRAS predicts response to Cetuximab
with a
sensitivity of 83% and a specificity of 76%. By addition of the KRAS
gene
35G > A mutation to wild-type PIK3CA, BRAF, and KRAS the CD-Cetuximab
predicts
response to Cetuximab with an increased sensitivity of 94%.

"Today, the KRAS mutation status is the only companion diagnostics
for
predicting response to Cetuximab and Panitumumab in patients with
advanced,
metastatic colorectal cancer. Both drugs are not approved for treating
patients
with colorectal cancer of UICC stage II and III. Our novel companion
diagnostic
CD-Cetuximab comprises the mutation status of three genes, PIK3CA,
BRAF and
KRAS, and is highly accurate in predicting response to Cetuximab in
patients
with CRC of UICC stage II and III" said Prof. André Rosenthal, CEO of
Signature
Diagnostics. "The development of companion diagnostics that predict
response to
Cetuximab in CRC patients of UICC stage II and III, opens the way for
novel
pivotal trials, that may lead to label extension of anti-EGFR antibodies
in the
adjuvant setting of CRC."

About Signature Diagnostics AG

Signature Diagnostics AG is a molecular diagnostics company based in
Potsdam,
Germany, focusing on the development and commercialization of novel
molecular
oncology diagnostic products for early detection (screening) and
prognosis of
cancer. The company has completed development of its first two
diagnostic
products for colorectal cancer screening ("Detector C/C+") and
prognosis
("Predictor C"), which will be launched in 2011 in its own ISO 15189
certified
service laboratory. Using its state-of-the-art technologies in tissue and
blood
sample collection, molecular pathology, Xenopatient™ platform,
genome-wide
profiling, data mining, and biostatistics, the company collaborates
with
clinical, pharmaceutical, and diagnostic partners. Signature
Diagnostics
sponsors and conducts large prospective, multicenter clinical trials with
more
than 33 primary care hospitals and several dozen colonoscopy centers in
Germany
to discover and validate biomarkers in oncology.

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